-16.96(-0.23%)

+6.35(+0.41%)

+0.27(+0.44%)

-5.90(-0.44%)

-0.20(-1.17%)

-0.01(-0.71%)

Setback for Novartis

Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.

Novartis (NVS) suffered a setback when the U.S. Food and Drug Administration (:FDA) and Cardiovascular and Renal Drugs Advisory Committee (CRDAF) voted against the approval of the candidate RLX030 (serelaxin) for the treatment of acute heart failure.

The news was diasppointing as Novartis had presented encouraging efficacy and safety data from a phase II and phase III study wherein it was observed that RLX030 improved the symptoms of acute heart failure (AHF.TO).

We note that the FDA will consider the recommendation of the Advisory Committee for its review of the Biologics License Application (:BLA) for RLX030 but not necessarily follow it.

We note that the FDA granted Breakthrough Therapy (BT) designation status to RLX030 in Jun 2013.

Nevertheless, Novartis plans to work closely with the FDA on the future development of RLX030.

Meanwhile, a global phase III study is underway on RLX030 and results are expected in 2016.

Last week, Novartis received positive news when the FDA approved Xolair for an additional indication. Xolair is now approved in the U.S. for the treatment of chronic idiopathic urticaria (CIU), in adults and adolescents (12 years and above) with inadequate response to H1-antihistamine treatment.

CIU is known as chronic spontaneous urticaria (CSU) outside the U.S. Xolair is already approved in the U.S. for moderate-to-severe persistent allergic asthma. Earlier this month, Xolair won approval for the CSU indication (as a combination therapy) in Europe.